Manufacturing Engineer SR

A Brief Overview The Contract Manufacturing Organization (CMO) Quality Specialist position will ensure quality in the day to day activities of the manufacturing organizations of our electro mechanical devices. It will ensure products meets established quality standards throughout the manufacturing process. The position will also provide direct support to Quality Management/Quality Engineering personnel regarding operation of the department and Quality System.

It will provide support to other departmental activities as directed. This position performs a wide array of activities related to:
Manufacturing Support, Change Control, Nonconformance Records (Client), Corrective and Preventive Action (CAPA), Product Surveillance, New Markets and Risk Management. Manufacturing Support, will include but not limited to: monitoring and improving first pass yield, analyzing sources of and reducing scrap, analyzing sources of quality issues and prompt resolution. The position will ensure the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated.

Quality and Manufacturing Operations Coordinate teams to solve manufacturing quality problems in a timely fashion. For example. Analyze scrap data and identity methods of reduction. Review yield data and recommend process improvements to increase it. Review process flow to identify sources of inefficiencies and methods to improve through put. Act as a liaison between quality and contract manufacturing departments. Initiate and/or support the development of protocols and final reports for manufacturing or other quality control projects.

Support manufacturing needs by ensuring proper testing is in place for raw materials, finished goods, validation, in-process material and final products is completed accurately, timely and documented correctly.

Support manufacturing investigations and implement corrective and preventive actions, to improve product quality. Analyze quality data and identify areas for improvement.

Support other Quality System functions as assigned by Quality Management that are related to documentation review, equipment calibration, nonconformance review, Out of Specification (OOS), Corrective and Preventative Actions, product complaint investigations (if applicable), audits, and other tasks as directed.

Participate with federal, state, and local regulatory officials during regulatory inspections. Support internal and vendor quality system audits.

Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical devices.

Provides support to Quality Management and Engineering personnel and perform other duties as assigned.

• Bachelor's Degree in Physical Science or Engineering or equivalent experience
• 2+ years Medical Device or Pharmaceutical Industry or similar experience.
• 2+ years In a Quality Role.
• 2+ years Working with electromechanical device manufacturing or contract manufacturing.
• 2+ years In Manufacturing Quality or Operations Role

• Experience with Power BI or equivalent tool
• ASQ Certifications or equivalent

• Knowledge of quality requirements for medical device / pharmaceutical organization.
• Quality experience may include quality testing (electrical systems), QA/Regulatory, and/or Validation.
• Experience with Statistical Analysis of Data.
• Experience with Statistical Sampling requirements for Process Validation.
• Knowledge of quality systems, quality techniques, current regulatory requirements and technical issues resolution.
• Ability to prepare testing protocols and reports, operating documents and procedures
• Ability to work with minimal supervision and to make effective decisions for issues of a diverse and complex scope when required.
• Computer skills in Microsoft Word, Excel, PowerPoint, Visio;
  Adobe; and Quality System Management Software.
• Experience in root cause analysis tools, CAPA, Client, SCAR investigations.
• Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
• Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines.
• Technical writing skills.
• Highly effective communication skills. Ability to work with company staff and communicate effectively throughout the organization.
• Manage multiple priorities and work with interruptions.
• Demonstrated history of teamwork and cross functional collaboration.